Medical Devices

Product safety is a priority for every manufacturer, as is the importance of knowledge of legislation and regulations to ensure the ultimate goal of 'preventive protection' for the consumer and make sure your product is on “state of the art”. Due to Kiwa's expertise, medical device companies can demonstrate that they meet the essential requirements for medical devices and gain access to the European market, as well as obtaining prerequisites for access to other global markets.

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ISO 13485 is a universal standard that extends its benefits to organizations involved in every facet of the medical device product life cycle. Regardless of your organization's type, size, or the specific medical products you offer, ISO 13485 can be integrated into your operations. Its adaptability allows it to be employed from the initial conceptualization of a medical device through to production, post-production, and the final decommissioning and disposal stages.

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Testing services for medical devices are functional to demonstrate products will reliably and safely be performing in use, for a preventive protection of end-users. For this, Medical Devices must be subjected to rigorous testing in order to meet the highest quality standards.

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Kiwa Italy, Kiwa Turkey and Kiwa Dare Services boast a wide and in-depth experience as Notified Bodies in medical devices certification, with thousands of products already certified.

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